Study Startup & Essential Documents Specialist - IUVO BIOSCIENCE OPERATIONS, LLC

iuvo BioScience is a Premier Partner Research Organization serving the Medical Device, Pharmaceutical, and Ophthalmic industries. We provide strategic guidance and testing services – from research to release - leveraging our preclinical testing, CMC/technical services, and clinical research experience to deliver exquisite science, develop valuable insights, and author flawless documentation. We do it all with a commitment to exceptional service.

 We offer a comprehensive benefits package (medical/dental/vision/401k/PTO) and the opportunity to broaden your experience working with top level medical device and pharmaceutical clients to improve the quality of life for patients and consumers around the world.

We currently have an opening for a Study Startup & Essential Documents Specialist to join our Clinical team.

SUMMARY

The Study Startup and Essential Documents Specialist (SSEDS) is responsible for supporting site start-up activities, including collection and review of essential documents for assigned investigative sites and Central IRB activities on a project and site-level. As a member of the Clinical organization, the SSEDS is responsible for assigned clinical programs and sites.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Manage essential documents at a study-level from study start-up through close-out and at a site-level from site selection through close-out inclusive of IRB activities
• Complete activities to confirm study and site-level eTMF completeness and document quality
  • Set-up and maintenance of study-specific Regulatory Trackers as needed (in lieu of an electronic tracking system)
  • Ongoing review of Regulatory Trackers (or electronic tracking system)
• Responsible for Central IRB Management on a project and site-level
• Complete Study-level IRB submissions inclusive of but not limited to:
  • Assist with the development of Informed Consent Form and patient facing materials such as phone scripts, patient diaries, and advertisements as needed in preparation of study level IRB submission.
  • Study-level close-out activities as applicable
• Complete Site-level IRB submissions inclusive of but not limited to:
  • Review site level ICFs, collaborate with sites re: updates
  • Review of site-specific materials (e.g., patient facing materials)
  • Support sites with the management and submission of continuing review
  • Site-level IRB close-out activities as applicable
• Independently accountable for study start-up for assigned clinical sites
  
  • Serve as the primary point of contact for assigned sites for start-up
  • Assist sites with the completion of IRB applications and submissions
  • Provide guidance and instruction on site completion of essential documents
  • Send study start-up/required site activation documents to assigned clinical sites
  • Organize, prepare, and ship applicable clinical study binders to clinical sites (regulatory binders, questionnaires, etc.) as needed
• Collect and carefully review essential documents in accordance with Sponsor specifications
• Responsible for Essential Document Quality, Completeness, and Processing
  • Verify documents meet ALCOAC standards and are aligned with ICH/GCP and SOP requirements
  • Follow study specific TMF Plan for classification of documents within the eTMF
  • Collaborate with eTMF Administrator re: study-specific updates needed to the Veeva system as applicable
  • Follow up with sites re: essential document action items through to resolution
• Track site essential documents and maintain study trackers as assigned to provide real-time updates to Sponsor as requested
• Primary point of contact for sites during the start-up process and essential document contact for the duration of the study (site activation forward)
• Responsible for site-level essential document Action Item (AI) follow-up with sites (e.g., start-up/site activation documents, expired documents, missing documents, document updates) from the time of site-selection through site close-out
• Collaborate with internal and external team members. Inclusive of but not limited to:
  • Assist with eTMF follow-up required as a result of internal or external eTMF audits or site-level audit findings pertaining to the ISF
  • Attend internal and external team calls to stay informed of current study status and provide feedback/updates as needed
  • Develop collaborative relationships with investigative sites and internal and external team members. Review pertinent regulations to develop and communicate proactive solutions to start-up issues and challenges.
  • Provide recommendations for improvement of project or divisional efficiencies based on work experience and observations
  • Escalate site issues to applicable project team member
•  Read and adhere to client-approved or iuvo SOPs
• Other duties as assigned

QUALIFICATIONS & REQUIREMENTS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

 EDUCATION and/or EXPERIENCE

• Bachelor’s degree or equivalent job experience preferred
• A clinical background with strong clinical site management/study start-up experience
• Experience collecting, reviewing, and submitting regulatory documents and communicating with investigative sites is highly preferred 

      COMPUTER SKILLS

• Experience working with eTMF systems is preferred
• Proficiency with Microsoft Office (Word, Excel, Outlook, Teams) and other software/programs as applicable to position   

    COMMUNICATION SKILLS

This position requires a person who communicates effectively both verbally and in writing with clinicians, clients, vendors, and internal project team members through demonstration of:    

• Excellent presentation and interpersonal skills, including clear, succinct, and timely communication  

• Sharing ideas in a constructive manner  

• Listening to and objectively considering ideas and suggestions from others  

• Keeping commitments  

• Keeping others informed of work progress, timetables and issues  

• Read and comprehend work instructions/SOPs and protocols and write clear, concise communications and documentation  

    OTHER SKILLS and ABILITIES

• Must be able to efficiently schedule/perform follow-up of tasks, manage multiple priorities, and organize time with a strong attention to detail and analytical skills

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is regularly required to sit or stand at a desk, talk and hear.

WORK ENVIRONMENT and LOCATION:

This is a remote position. A suitable home office area is required. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

LOCATION Remote

TRAVEL As required, estimated as <5%.

DISCLAIMER

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.

iuvo BioScience is an Equal Opportunity Employer